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Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS) (Xtravent)

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lung protective ventilation
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring acute respiratory distress syndrome, extracorporeal lung support, hypoxia, hypercapnia, acute respiratory distress syndrome (ARDS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The trial subjects are patients aged 18 years or older who have developed severe ARDS. Following the American-European Consensus Conference on ARDS, severe ARDS is defined as an oxygenation index (PaO2/FIO2) < 200 mmHg. These parameters must be present for a duration of at least 2 hours.

Exclusion Criteria:

  • age < 18 years
  • decompensated heart insufficiency
  • acute coronary syndrome
  • severe chronic obstructive pulmonary disease
  • advanced tumour conditions with life expectancy < 6 months
  • chronic dialysis treatment
  • lung transplant patients
  • proven Heparin-induced thrombocytopenia (HIT)
  • morbid obesity (BMI >) 40
  • Child Class B and C cirrhosis of the liver, acute fulminant hepatic failure
  • severe peripheral arterial occlusive disease (pAVK III - IV), absence of limb doppler pulse
  • brain injury (GCS < 9 + CT pathology)

Sites / Locations

  • University Hospital Regensburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Intervention: Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria.

no device: Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).

Outcomes

Primary Outcome Measures

Ventilator free days within 28 days after enrollment

Secondary Outcome Measures

hospital mortality, organ-failure free days, pulmonary gas exchange

Full Information

First Posted
October 2, 2007
Last Updated
March 1, 2011
Sponsor
University of Regensburg
Collaborators
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00538928
Brief Title
Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS)
Acronym
Xtravent
Official Title
Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Regensburg
Collaborators
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A prospective, randomized study will be performed investigating the effects of a pumpless extracorporeal interventional lung assist [iLA] on the implementation of a lung-protective ventilatory strategy in patients with acute respiratory distress syndrome [ARDS] with a PaO2/FiO2 ratio < 200. The duration of ventilation, intensive care and hospital stay and in-hospital mortality will be investigated.
Detailed Description
Evaluation group: Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria. Control group: Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
acute respiratory distress syndrome, extracorporeal lung support, hypoxia, hypercapnia, acute respiratory distress syndrome (ARDS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Intervention: Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria.
Arm Title
2
Arm Type
Active Comparator
Arm Description
no device: Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).
Intervention Type
Other
Intervention Name(s)
lung protective ventilation
Intervention Description
tidal volume 6 ml/kg ideal body weight
Primary Outcome Measure Information:
Title
Ventilator free days within 28 days after enrollment
Time Frame
28 days
Secondary Outcome Measure Information:
Title
hospital mortality, organ-failure free days, pulmonary gas exchange
Time Frame
28 days - 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The trial subjects are patients aged 18 years or older who have developed severe ARDS. Following the American-European Consensus Conference on ARDS, severe ARDS is defined as an oxygenation index (PaO2/FIO2) < 200 mmHg. These parameters must be present for a duration of at least 2 hours. Exclusion Criteria: age < 18 years decompensated heart insufficiency acute coronary syndrome severe chronic obstructive pulmonary disease advanced tumour conditions with life expectancy < 6 months chronic dialysis treatment lung transplant patients proven Heparin-induced thrombocytopenia (HIT) morbid obesity (BMI >) 40 Child Class B and C cirrhosis of the liver, acute fulminant hepatic failure severe peripheral arterial occlusive disease (pAVK III - IV), absence of limb doppler pulse brain injury (GCS < 9 + CT pathology)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bein, Professor Dr.
Organizational Affiliation
University Hospital Regensburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steffen Weber-Carstens, Dr.
Organizational Affiliation
Charite University Hospital Berlin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thomas Staudinger, Prof
Organizational Affiliation
University Hospital Vienna, Austria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sven Bercker, MD
Organizational Affiliation
University Hospital Leipzig, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ralph Müllenbach, MD PhD
Organizational Affiliation
University Hospital Würzburg, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rolf Dembinski, MD PhD
Organizational Affiliation
University Hospital Aachen, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16540950
Citation
Bein T, Weber F, Philipp A, Prasser C, Pfeifer M, Schmid FX, Butz B, Birnbaum D, Taeger K, Schlitt HJ. A new pumpless extracorporeal interventional lung assist in critical hypoxemia/hypercapnia. Crit Care Med. 2006 May;34(5):1372-7. doi: 10.1097/01.CCM.0000215111.85483.BD.
Results Reference
background
PubMed Identifier
23306584
Citation
Bein T, Weber-Carstens S, Goldmann A, Muller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy ( approximately 3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.
Results Reference
derived

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Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS)

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